Key Considerations For Achieving Digital Trial Success

The pharmaceutical industry spent approximately four times more on R&D in 2015 than in 1995, with no corresponding increase in the number of drugs approved by the FDA (1). These spiraling costs can be attributed to a transition away from the traditional “one size fits all” model, which has led to difficulty defining clinical endpoints and an inability to recruit or retain patients.

As a result, digital disruption in the form of new wearables, sensors and medical devices are emerging to enable pharmaceutical and medical device companies to generate new types of datasets. Moreover, artificial intelligence and machine learning can generate new insights and responsive digital biomarkers from these new datasets. All of these factors are coming together to enable a growing revolution that can combat declining R&D efficiency: the implementation of digital trials.

Digital trials, which are defined as the use of mHealth and mobile technology to capture insights outside of a traditional clinical setting, present solutions to the challenges being faced by the pharma industry, making them increasingly appealing to patients, healthcare providers and payers. The global movement towards digital clinical trials has been occurring over the past several years and it offers drug companies the opportunity to leverage the technical advances in this huge and growing mhealth market, estimated to be worth $163 billion by 2020 (1).